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An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514376-40-00
Acronym
MK-1022-010
Enrollment
10
Registered
2025-04-21
Start date
2025-10-15
Completion date
Unknown
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Early-Stage Triple Negative Breast Cancer (TNBC) or Hormone Receptor Low Positive/Human Epidermal Growth Factor Receptor 2 Negative (HR-low+/HER2-) Breast Cancer

Brief summary

Part 1: Number of Participants Experiencing an Adverse Event (AE), Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Part 2: Number of Participants Experiencing an Adverse Event (AE), Part 2: Number of Participants who Discontinued Study Treatment Due to an AE

Detailed description

Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0, Part 2: Event-Free Survival (EFS), Part 2: Overall Survival (OS), Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Part 2: Residual Cancer Burden (RCB)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGEPIRUBICIN
DRUGPACLITAXEL
DRUGCYCLOPHOSPHAMIDE
DRUGDOXORUBICIN
DRUGCARBOPLATIN
DRUGOLAPARIB
DRUGCAPECITABINE

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: Number of Participants Experiencing an Adverse Event (AE), Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Part 1: Number of Participants who Discontinued Study Treatment Due to an AE, Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0, Part 2: Number of Participants Experiencing an Adverse Event (AE), Part 2: Number of Participants who Discontinued Study Treatment Due to an AE

Secondary

MeasureTime frame
Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0, Part 2: Event-Free Survival (EFS), Part 2: Overall Survival (OS), Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS), Part 2: Residual Cancer Burden (RCB)

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026